Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections

Urinary Tract Infections Clinical Trial

Official title:

Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019874
• Other study ID #: Cranberry
• Status: Completed
• Start date: January 2017
• Est. completion date: February 2019

Study information

• Verified date: February 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main focus of this observational study is to analyze the possible effects of cranberry dietary supplements on the intestinal microbiota in women with recurrent uncomplicated urinary tract infections. In a secondary analysis the possible influence of the microbiota changes on the recurrence frequency in the follow-up should be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• chronic recurrent urinary tract infections (=3 infections per year or 2 infections in the last 6 months)

Exclusion Criteria:

• renal insufficiency (GFR <60),
• anatomical or known structural causes of urinary tract infections
• regular consumption of probiotics or probiotic yogurts (at least 5x / week)
• intake of antibiotics in the last 4 weeks
• intake of Marcumar
• simultaneous participation in another study

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Cranberry Extract
3 x Cystorenal Cranberry plus daily for 6 months (contains 300 mg Cranberry-Extract, 100 mg Pumpkin seeds-Extract, 20 mg Vitamin C und 0,47 mg Riboflavin)

Locations

Country	Name	City	State
Germany	Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stool analysis: Intestinal microbiome by sequencing 16S rRNA		Baseline, 4 weeks, 8 weeks, 6 months
Primary	Number of urinary tract infections		In the 6-month prospective observation period compared to a 6-month retrospective period
Secondary	Quality of life (SF-36)		Baseline, 4 weeks, 8 weeks, 6 months